Industry News

Disc Medicine Initiates BEACON, a Phase 2 Clinical Study of Bitopertin in Patients with Erythropoietic Protoporphyria (EPP) and X-linked Protoporphyria (XLP)

08/22/2022

BEACON study will evaluate bitopertin as a potential disease-modifying treatment for patients with Erythropoietic Protoporphyria (EPP) or X-linked Protoporphyria (XLP) Key assessments include changes in protoporphyrin IX levels, safety, tolerability and measures of photosensitivity; preliminary data expected by 1H 2023 Excerpt from the Press Release: WATERTOWN, Mass., Aug. 10, 2022 /PRNewswire/ — Disc Medicine, a clinical-stage biotechnology…

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Olema Oncology Advances OP-1250 into Phase 2 Monotherapy Expansion in Patients with ER+/HER2- Advanced Breast Cancer

08/19/2022

Excerpt from the Press Release: SAN FRANCISCO, Aug. 09, 2022 (GLOBE NEWSWIRE) — Olema Pharmaceuticals, Inc. (“Olema” or “Olema Oncology,” Nasdaq: OLMA), today announced the advancement of OP-1250, a complete estrogen receptor (ER) antagonist (CERAN) and a selective ER degrader (SERD), into Phase 2 clinical development for the treatment of ER+/HER2- metastatic breast cancer. “We are excited…

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Biora Therapeutics Announces Successful Completion of Device Performance Study in Ulcerative Colitis Patients for its Targeted Therapeutics Platform

08/19/2022

All Devices Successfully Detected Colon Entry in Patients with Active Ulcerative Colitis Excerpt from the Press Release: SAN DIEGO, Aug. 10, 2022 (GLOBE NEWSWIRE) — Biora Therapeutics, Inc. (Nasdaq: BIOR), the biotech company that is reimagining therapeutics, today announced topline results from its recently completed study PM-602: A Scintigraphic Study to Evaluate the Localization and Delivery…

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Nabriva Therapeutics Completes Patient Enrollment in Phase 1 Trial of XENLETA® (lefamulin) in Adult Patients with Cystic Fibrosis

08/18/2022

– Topline Data Expected First Quarter 2023 – Excerpt from the Press Release: DUBLIN, Ireland and FORT WASHINGTON, Pa., Aug. 11, 2022 (GLOBE NEWSWIRE) — Nabriva Therapeutics plc (NASDAQ: NBRV), a biopharmaceutical company engaged in the commercialization and development of innovative anti-infective agents to treat serious infections, announced the completion of patient enrollment in its…

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iNtRON developed New CRISPR/Cas technology specific for Bacteriophage as PHAGERUS® Platform

08/18/2022

CRISPR/Cas system for bacteria that are not E. coli or Streptococcus pyogenes Customized gene editing technology for unique modified-bacteriophages To validate efficacy of SARS-CoV-2 mimotopes loaded PHAGERUS® platform Excerpt from the Press Release: BOSTON and SEOUL, South Korea, Aug. 9, 2022 /PRNewswire/ — iNtRON Biotechnology (“iNtRON”, www.intodeworld.com) announced today that iNtRON has developed its unique CRISPR/Cas system customized for the genetic modification of certain bacteria…

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Lucira Announces Health Canada Authorization of First and Only 99% Accurate At-Home Covid & Flu Test

08/17/2022

Excerpt from the Press Release: EMERYVILLE, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) — Lucira Health, Inc. (Nasdaq: LHDX) (“Lucira Health,” “Lucira” or the “Company”), a medical technology company focused on the development and commercialization of transformative and innovative infectious disease tests, today announced that Health Canada has granted Authorization under Interim Order for the emergency…

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Graphite Bio Doses First Patient with Investigational Gene Editing Therapy GPH101 for Sickle Cell Disease

08/17/2022

GPH101, now called nulabeglogene autogedtemcel (nula-cel), designed to directly correct the genetic mutation that causes sickle cell disease Initial proof-of-concept data from Phase 1/2 CEDAR trial anticipated in mid-2023 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Graphite Bio, Inc. (Nasdaq: GRPH), a clinical-stage, next-generation gene editing company harnessing the power of high-efficiency precision…

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ALX Oncology Announces First Patient Dosed in Phase 2 Investigator-Sponsored Trial of Evorpacept in Combination with Cetuximab and Pembrolizumab in Patients with Advanced Colorectal Cancer

08/17/2022

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Aug. 11, 2022 (GLOBE NEWSWIRE) — ALX Oncology Holdings Inc., (“ALX Oncology”) (Nasdaq: ALXO), a clinical-stage immuno-oncology company developing therapies that block the CD47 checkpoint pathway, today announced the initiation of a Phase 2 investigator-sponsored study of evorpacept, a next generation CD47 blocker, in combination with…

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Homology Medicines Announces Optimized, In Vivo Gene Therapy Candidate for the Treatment of Metachromatic Leukodystrophy

08/16/2022

– Candidate Showed Ability to Target Central Nervous System and Peripheral OrgansFollowing a Single I.V. Administration in MLD Model, a Key Differentiator from AvailableTreatments and Product Candidates –        – Data Demonstrated Biodistribution to Brain Regions and Multiple Cell Types –        – Optimizations Included Significant Improvements in Expression, Productivity and Packaging – – Homology Seeks Partner…

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Agios Announces Publication of Phase 2 Data in The Lancet Demonstrating Safety and Efficacy of PYRUKYND® (mitapivat) in Non-transfusion-dependent α- and β-Thalassemia

08/16/2022

– In Adults with Non-transfusion-dependent α- or β-Thalassemia, PYRUKYND® Induced ≥1.0 g/dL Hemoglobin Increase from Baseline in 16 of 20 (80%) Patients Between Weeks 4-12 – – PYRUKYND® Safety Profile Consistent with Label for FDA-approved Indication in Pyruvate Kinase Deficiency – – Actively Enrolling Phase 3 ENERGIZE and ENERGIZE-T Studies Evaluating PYRUKYND® in Adults with Non-transfusion-dependent and Transfusion-dependent α-…

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